UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000009995 |
|---|---|
| Receipt number | R000011701 |
| Scientific Title | Utility of Computed Tomographic Enteroclysis/Enterography for the Assessment of Mucosal Healing in Crohn's Disease |
| Date of disclosure of the study information | 2013/02/07 |
| Last modified on | 2014/12/18 18:35:25 |
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Basic information
Public title
Utility of Computed Tomographic Enteroclysis/Enterography for the Assessment of Mucosal Healing in Crohn's Disease
Acronym
Utility of Computed Tomographic Enteroclysis/Enterography for the Assessment of Mucosal Healing
Scientific Title
Utility of Computed Tomographic Enteroclysis/Enterography for the Assessment of Mucosal Healing in Crohn's Disease
Scientific Title:Acronym
Utility of Computed Tomographic Enteroclysis/Enterography for the Assessment of Mucosal Healing
Region
| Japan |
Condition
Condition
Crohn's disease
Classification by specialty
| Gastroenterology |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
the purpose of the present study was to compare the findings from Computed Tomographic Enteroclysis/Enterography(CTE) with those from examination of the mucosal surface and to determine whether the state of mucosal healing can be determined by CTE.
Basic objectives2
Efficacy
Basic objectives -Others
Trial characteristics_1
Confirmatory
Trial characteristics_2
Pragmatic
Developmental phase
Not applicable
Assessment
Primary outcomes
Diagnostic yield of mucosal healing by CTE
Key secondary outcomes
Diagnostic yield of erosion and ulcer by CTE
adverse event
Base
Study type
Observational
Study design
Basic design
Randomization
Randomization unit
Blinding
Control
Stratification
Dynamic allocation
Institution consideration
Blocking
Concealment
Intervention
No. of arms
Purpose of intervention
Type of intervention
Interventions/Control_1
Interventions/Control_2
Interventions/Control_3
Interventions/Control_4
Interventions/Control_5
Interventions/Control_6
Interventions/Control_7
Interventions/Control_8
Interventions/Control_9
Interventions/Control_10
Eligibility
Age-lower limit
| 8 | years-old | <= |
Age-upper limit
| 85 | years-old | >= |
Gender
Male and Female
Key inclusion criteria
Of the patients who underwent CTE for Crohn's disease at our hospital, the cases were examined whose mucosal findings could be confirmed by colonoscopy, capsule endoscopy, balloon endoscopy, barium enteroclysis for the small intestine, or with the surgically resected specimens.
Key exclusion criteria
no exclusion criteria
Target sample size
40
Research contact person
Name of lead principal investigator
| 1st name | |
| Middle name | |
| Last name | Shinichi Hashimoto |
Organization
Yamaguchi University Graduate School of Medicine
Division name
Department of Gastroenterology and Hepatology
Zip code
Address
1-1-1 Minami-Kogushi, Ube, Yamaguchi 755-8505, Japan
TEL
+81-836-22-2241
has-333@yamaguchi-u.ac.jp
Public contact
Name of contact person
| 1st name | |
| Middle name | |
| Last name | Shinichi Hashimoto |
Organization
Yamaguchi University Graduate School of Medicine
Division name
Department of Gastroenterology and Hepatology
Zip code
Address
1-1-1 Minami-Kogushi, Ube, Yamaguchi 755-8505, Japan
TEL
+81-836-22-2241
Homepage URL
has-333@yamaguchi-u.ac.jp
Sponsor or person
Institute
Department of Gastroenterology and Hepatology, Yamaguchi University Graduate School of Medicine
Institute
Department
Personal name
Funding Source
Organization
Department of Gastroenterology and Hepatology, Yamaguchi University Graduate School of Medicine
Organization
Division
Category of Funding Organization
Other
Nationality of Funding Organization
Other related organizations
Co-sponsor
Name of secondary funder(s)
IRB Contact (For public release)
Organization
Address
Tel
Secondary IDs
Secondary IDs
NO
Study ID_1
Org. issuing International ID_1
Study ID_2
Org. issuing International ID_2
IND to MHLW
Institutions
Institutions
Other administrative information
Date of disclosure of the study information
| 2013 | Year | 02 | Month | 07 | Day |
Related information
URL releasing protocol
Publication of results
Published
Result
URL related to results and publications
Number of participants that the trial has enrolled
Results
Results date posted
Results Delayed
Results Delay Reason
Date of the first journal publication of results
Baseline Characteristics
Participant flow
Adverse events
Outcome measures
Plan to share IPD
IPD sharing Plan description
Progress
Recruitment status
Completed
Date of protocol fixation
| 2012 | Year | 12 | Month | 29 | Day |
Date of IRB
Anticipated trial start date
| 2012 | Year | 12 | Month | 29 | Day |
Last follow-up date
Date of closure to data entry
Date trial data considered complete
Date analysis concluded
| 2013 | Year | 04 | Month | 08 | Day |
Other
Other related information
All patients were divided into either the active group or inactive group according to CTE findings.
Mucosal findings were evaluated by colonoscopy, capsule endoscopy, balloon endoscopy,or examination of the resected specimen.
We compared the clinical background and mucosalfinding of each group, retrospectively.
Management information
Registered date
| 2013 | Year | 02 | Month | 07 | Day |
Last modified on
| 2014 | Year | 12 | Month | 18 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000011701
